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HFIT Versus TENS Study for Chronic Low Back and Knee Pain

Sponsor
Hinge Health, Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05821530
Collaborator
(none)
288
Enrollment
1
Location
3
Arms
1.4
Anticipated Duration (Months)
199.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A high-frequency impulse therapy (HFIT) device (Enso, San Francisco, CA) is a portable device for the treatment of musculoskeletal pain. This three-arm randomized controlled trial study compares a HFIT group to a standard transcutaneous electrical nerve stimulator (TENS) group and a control group.

Condition or Disease Intervention/Treatment Phase
  • Device: HFIT
  • Device: TENS
  • Other: Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
288 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Clinical Trial Evaluating the Effectiveness of High-frequency Impulse Therapy Versus Transcutaneous Electronic Nerve Stimulator for Treatment of Chronic Low Back and Knee Pain
Anticipated Study Start Date :
Apr 24, 2023
Anticipated Primary Completion Date :
Jun 7, 2023
Anticipated Study Completion Date :
Jun 7, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HFIT

Participants received a HFIT device to treat their chronic pain and took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists. Participants were encouraged to use the HFIT device for at least 1 hour daily for 4 weeks.

Device: HFIT
At least 1 hour daily for 4 weeks
Other Names:
  • Enso

    		•
    Experimental: TENS

    Participants received a TENS device to treat their chronic pain and took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists. Participants were encouraged to use the TENS device for at least 1 hour daily for 4 weeks.

    Device: TENS
    At least 1 hour daily for 4 weeks
    Active Comparator: Control

    Participants took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists.

    Other: Control
    Users will continue to use the digital MSK program as needed
    Other Names:
  • Digital MSK program

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain MCID [Baseline and Week 4]

      Pain will be measured by the Numeric Pain Rating Scale, ranging from 0 (no pain) to 100 (worst possible pain). The minimal clinically important difference (MCID) of pain will be achieved (0/1) if there is at least a 34% or 23 point improvement, as based on literature.

    Secondary Outcome Measures

    1. Function MCID (Back) [Baseline and Week 4]

      Back function will be measured by the Roland-Morris Disability Questionnaire 11-item (RMDQ-11, 0-100, higher indicates worse function) scores for back users. Function MCID will be achieved (0/1) if there is at least a 30% improvement in RMDQ-11, as based on literature.

    2. Function MCID (Knee) [Baseline and Week 4]

      Knee function will be measured by the Knee Injury and Osteoarthritis Outcome Score - Physical Short Form (KOOS-PS, 0-100, higher indicates worse function). Function MCID will be achieved (0/1) if there is at least an 8 point improvement in KOOS-PS, as based on literature.

    3. Anxiety [Baseline and Week 4]

      Anxiety will be assessed by the Generalized Anxiety Disorder 2-item (GAD-2, 0-6, higher is worse) scores. A score of 3 or higher is defined as screening in for having anxiety, based on literature. The percentage of users who screen in for anxiety in each group will be compared.

    4. Depression [Baseline and Week 4]

      Depression will be assessed by the Patient Health Questionnaire 2-item (PHQ-2, 0-6, higher is worse) scores. A score of 3 or higher is defined as screening in for having depression, based on literature. The percentage of users who screen in for depression in each group will be compared.

    5. Opioid use [Baseline and Week 4]

      Opioid use data will be collected through survey questions. The percentage of users who use opioids in each group during the study will be compared.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18 or over and under age 65

    • Baseline pain is 40 or more out of 100 on a NPRS

    • Member of digital MSK program's chronic back or knee pain program, after January 1, 2023

    • Member engaged in the most recent 3 weeks

    • Experiencing chronic pain for at least 3 months

    • Subject able to understand and provide informed consent

    • Has an email account

    Exclusion Criteria:

    • Diagnosis of cancer/malignant tumors in the last 5 years

    • Back or knee surgery in the last 6 months

    • Has a cardiac pacemaker, implanted defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other implanted electronic device

    • Patients with history of opioid, alcohol, or drug abuse in the last 1 year

    • Cognitive, behavioral, neurologic, or psychiatric disorder (e.g., dementia, Parkinson's, schizophrenia, stroke) that may interfere with the study or prevent the subject from complying with the requirements of the protocol

    • Pregnant or plan on becoming pregnant in the next year

    • Have epilepsy

    • Have cardiovascular disease

    • Current pain (in the past 24 hours) is less than 40 out of 100 on a NPRS

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hinge Health, Inc San Francisco California United States 94105

    Sponsors and Collaborators

    • Hinge Health, Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hinge Health, Inc
    ClinicalTrials.gov Identifier:
    NCT05821530
    Other Study ID Numbers:
    • HFIT20223468
    First Posted:
    Apr 20, 2023
    Last Update Posted:
    Apr 20, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Hinge Health, Inc
    musculoskeletal
    chronic
    pain
    knee pain
    back pain
    Additional relevant MeSH terms:
    Back Pain
    Chronic Pain
    Low Back Pain

    Study Results

    No Results Posted as of Apr 20, 2023